Was den Menschen zum Menschen macht

Consent Regulation for Organ Donation

4 Min. Lesezeit

🇩🇪 Deutsche Version: Zustimmungsregelung Organspende

The consent regulation for organ donation is the basic legal form by which the permissibility of postmortem organ removal is determined. It does not touch the definition of death, but the normative condition of removal — and thus forms the second axis of transplantation ethics alongside the definition of death.

The five main forms

FormCountry (example)Characteristic
Informed consent (opt-in)USA, Japan, IsraelRemoval only after explicit consent
Decision regulationGermany (TPG amendment 2012)Active state duty to inform; citizens are called upon to decide but are not obligated
Narrow opt-out regulationAustria (OTG 2012)Whoever has not objected counts as a donor; no family veto
Extended opt-out regulationSwitzerland (from ca. Q3 2027)Like the narrow form, but relatives are consulted about the presumed attitude
Soft opt-outSpain (Real Decreto 1723/2012)Legally an opt-out regulation, in practice family involvement

Switzerland: referendum 2022, entry into force ca. 2027

On 15 May 2022, Switzerland decided by referendum to switch from the consent to the extended opt-out regulation (60.2 percent yes). Entry into force is expected ca. Q3 2027, after the establishment of a national objection register. In parallel, the SAMS revised its guidelines on the determination of death in 2025 — with the proposal to replace “irreversible” with “permanent” (see Permanence Thesis).

UK: Max and Keira’s Law

With the Organ Donation (Deemed Consent) Act 2019, in force since 20 May 2020 (“Max and Keira’s Law”), England carried out the switch from opt-in to opt-out. Wales had already made the switch in 2015, Scotland in 2021. The UK reform separates the consent regulation from the definition of death; the British brainstem death criterion remains unchanged.

The Spanish ONT model

With its soft opt-out and the highly professionalized ONT infrastructure, Spain has led the international donation statistics for decades — the finding: it is not the law alone that decides, but the infrastructure and the communication with families.

Substance-ontological position

The five forms are not morally equivalent. A genuine personal consent requires informedness, clarity of understanding, and a free act of the will. Silence is not necessarily consent — it can mean ignorance, repression, being overwhelmed, or decision aversion. Where informedness cannot be assumed, the presumed consent is not a free personal act but a legal fiction.

From this follows a graduated substance-ontological assessment:

  • Informed consent (opt-in), the decision regulation, and the soft opt-out are compatible with the Personalist Norm within limits, because they require an active act of the will of the person or a careful reconstruction of her presumed will by the relatives.
  • The narrow opt-out regulation and the extended opt-out regulation are problematic under the precautionary principle, because they presume consent in silence without the person’s informedness being empirically assured. The narrow opt-out regulation moreover structurally violates the Personalist Norm, because it declares the person a donor without that person ever having had to express a corresponding will.

The axis of consent is to be distinguished from the axis of the definition of death — yet both must be fulfilled simultaneously for a morally permissible organ removal. The Dead Donor Rule and the precautionary principle work together here.

Ontological classification

Subclasses: Informed Consent, Decision Regulation, Narrow Opt-Out Regulation, Extended Opt-Out Regulation, Soft Opt-Out

Connected with: Dead Donor Rule, Donation after Circulatory Death, Irreversible Loss of Brain Function

Sources: Generated by querying the Personhood ontology.

Further sources:

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